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FDA 510(k)

OMNIPRO SYSTEM

K-Number: K050143 · 2005-02-01

ApplicantMays and Associates, Inc.
Decision Date2005-02-01
Product CodeOLV
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

OMNIPRO SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Mays and Associates, Inc.. It received FDA 510(k) clearance on 2005-02-01 under 510(k) number K050143. The device is classified under product code OLV. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNIPRO SYSTEM?

OMNIPRO SYSTEM is a medical device that received FDA 510(k) clearance on 2005-02-01. The listed applicant is Mays and Associates, Inc.. The 510(k) number is K050143.

When did OMNIPRO SYSTEM receive FDA 510(k) clearance?

OMNIPRO SYSTEM received FDA 510(k) clearance on 2005-02-01, under 510(k) number K050143.

Who is the listed applicant for OMNIPRO SYSTEM?

The FDA 510(k) record lists Mays and Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OMNIPRO SYSTEM?

The FDA product code for OMNIPRO SYSTEM is OLV.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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